Quality by design

The European Medicines Agency (EMA) welcomes applications that include quality by design. Quality by design is an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines.

One of the goals of quality by design is to ensure that all sources of variability affecting a process are identified, explained and managed by appropriate measures. This enables the finished medicine to consistently meet its predefined characteristics from the start - so that it is 'right first time'.

Quality by design centres on the use of multivariate analysis, often in combination with modern process-analytical chemistry methods and knowledge-management tools to enhance the identification and understanding of critical attributes of materials and critical parameters of the manufacturing process. This enhanced understanding of product and process is used to build quality into manufacturing and provide the basis for continuous improvement of products and processes.

The concepts behind quality by design were introduced in international guidelines intended for the pharmaceutical industry between 2009 and 2012.

Applications including quality by design

The Agency welcomes applications that include quality-by-design aspects. These can include applications for marketing authorisation, variations to existing marketing authorisations and scientific advice.

Parallel assessment with the United States

EMA published the final report of its join pilot programme with the United States (US) Food and Drug Administration (FDA) for the parallel assessment of sections of applications relevant to quality by design in April 2017:

The report concludes that the both Agencies are strongly aligned on the implementation of quality by design concepts included in the ICH Q8, Q9 and Q10 guidelines.

It also foresees continued cooperation and support to innovation and global development of medicines of high quality for the benefit of patients.

The agencies are exploring potential joint activities with a focus on continuous manufacturing, additional emerging technologies, and expedited/accelerated assessments. EMA and FDA also host experts from each other’s agencies.

The pilot was initially launched for three years in 2011 and extended until April 2016.

Workshops

The Agency hosts workshops to explain the quality-by-design process and how to integrate this into applications: